The purpose of this study is to evaluate the effects of BMS-986371 on the drug levels of methotrexate, sulfasalazine and their main metabolites in healthy male adult participants.
This study will allow investigation of potential drug-drug interaction mediated through drug transporter proteins. During each part, blood samples will be collected at prespecified times for pharmacokinetic assessments. Subject safety will be monitored throughout the study. There will be approximately 16 subjects enrolled into each part.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Quotient Sciences Miami
Miami, Florida, United States
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])
Part 1
Time frame: Up to 22 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Part 1
Time frame: Up to 22 days
Maximum observed plasma concentration (Cmax)
Part 1
Time frame: Up to 22 days
AUC(0-T)
Part 2
Time frame: Up to 22 days
AUC(INF)
Part 2
Time frame: Up to 22 days
Cmax
Part 2
Time frame: Up to 22 days
Number of participants with adverse events (AEs)
Parts 1 and 2
Time frame: Up to 30 days post participant's last study treatment
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Specified dose on specified days